Implantable injection port and protective cap

ABSTRACT

A surgical fastening system for implantable devices is disclosed. The implantable device may contain a plurality of fasteners in pre-deployment position, may have a housing fitted over or around fit which contains a plurality of fasteners in pre-deployment position, or may be a part of a two-part system into which it fits. Accordingly, the present invention also encompasses a deployment system or tool that optionally positions the implantable device, and which causes the fasteners to move into post-deployment position. The fasteners may be staples, metal loops, coils, springs or hooks formed of biocompatible materials, including shape memory alloys such as NiTi.

RELATED APPLICATIONS

The present application is a continuation of U.S. application Ser. No.12/483,980, filed Jun. 12, 2009, which is a continuation of U.S.application Ser. No. 10/562,954, having a 35 U.S.C. §371 date of Dec.30, 2005 as a National stage application of PCT/US05/01958, filed Jan.21, 2005, which claims priority to U.S. Provisional Application No.60/538,674 filed Jan. 23, 2004, each of which is incorporated herein byreference in its entirety. U.S. application Ser. No. 12/483,980 is alsoa continuation-in-part of U.S. application Ser. No. 10/562,964, having a35 U.S.C. §371 date of Dec. 30, 2005 as a National stage application ofPCT/US04/30053, filed Sep. 15, 2004, which claims priority to U.S.Provisional Application No. 60/503,074 filed Sep. 15, 2003 and to U.S.Provisional Application No. 60/538,674 filed Jan. 23, 2004, each ofwhich is incorporated herein by reference in its entirety.

FIELD OF THE INVENTION

The present invention relates to the fields of implantable medicaldevices and surgical instruments and fasteners. The present inventionencompasses methods of fastening devices or implants in surgicalprocedures and the surgical fasteners and instruments used in theprocess.

BACKGROUND OF THE INVENTION

Surgical fasteners such as staples, clips, clamps, bands, tacks, orother wound or incision closure devices are commonly used in surgicalprocedures to allow a surgeon to fasten, secure and/or repair bodytissue. Examples of surgical fasteners are given in U.S. Pat. Nos.4,994,073 or 4,950,284 or 4,934,364 and 4,932,960.

Surgical fasteners have been used in surgical procedures to eliminatethe need for suturing, which is both time consuming and inconvenient. Inthese applications the surgeon often uses a fastener implanting deviceloaded with one or more surgical fasteners to accomplish in a fewseconds what would have taken many minutes to perform by suturing. Thisreduction in operating time reduces blood loss and trauma to thepatient.

Typically, such fastening systems have been used mainly for the closureof incisions or wounds, or to fasten tissues together. A surgicalfastening system that could be used with a number of types ofimplantable devices would be beneficial for surgeons. Currently,surgical devices that incorporate fastening systems often use extremelyspecialized systems that may be unnecessarily complicated and areunsuitable for adaptation to other applications. As a result, themajority of implantable devices are secured with sutures. For example,when inserting a gastric band and the associated access port, the portis sutured into place with 4 to 5 sutures against the rectus musclesheath. Such placement of the sutures is often challenging because theports are placed below several inches of fat, and suturing the portoften takes as long as placing the band itself. An improved fasteningsystem would allow easy, one-step attachment with security equivalent tothe sutured device.

The present invention overcomes such problems in the art.

SUMMARY OF THE INVENTION

The present invention encompasses surgical fastening systems wherein animplantable device either contains a plurality of fasteners inpre-deployment position, or wherein an implantable device may have ahousing fitted over the device, wherein the housing contains a pluralityof fasteners in pre-deployment position. Accordingly, the presentinvention also encompasses a deployment system that optionally positionsthe implantable device, and which causes the fasteners to move intopost-deployment position.

Features and advantages of the present invention will become appreciatedas the same become better understood with reference to thespecification, claims, and appended drawings wherein:

BRIEF DESCRIPTION OF THE DRAWINGS

The above objects and advantages of the present invention will be morefully understood by reference to the following description and annexeddrawings, in which:

FIG. 1 is an elevation view of a radial pivot fastener with staples inpre-deployment position;

FIG. 2 is an elevation view of the radial pivot fastener of FIG. 1 withstaples in deployed position;

FIG. 3 is a detail elevation view of the radial pivot fastener of FIG. 1with staples in pre-deployment position;

FIG. 4 is a detail elevation view of the radial pivot fastener of FIG. 2with staples in deployment position;

FIG. 5 is an elevation view of a delivery system;

FIG. 6 is a cutaway view of the delivery system shown in FIG. 5 and aport fastener;

FIG. 7 is a detail cutaway elevation view of the distal end of thedelivery system of FIG. 6 and a port fastener in pre-deploymentposition;

FIG. 8 is a detail cutaway elevation view of the distal end of thedelivery system of FIG. 6 and a port fastener in deployment position;

FIG. 9 is an elevation view of a pencil grip handle configuration for adelivery system;

FIG. 10 is a detail cutaway elevation view of the handle of the deliverysystem of FIG. 9 shown in a starting position;

FIG. 11 is a detail cutaway elevation view of the handle of the deliverysystem of FIG. 9 shown in a fired position;

FIG. 12 is an elevation view of a pistol grip handle configuration for adelivery system;

FIG. 13 is a detail elevation view of the handle of the delivery systemof FIG. 12 shown in a starting position;

FIG. 14 is a detail elevation view of the handle of the delivery systemof FIG. 12 shown in a fired position;

FIG. 15 is an elevation view of another pistol grip handle configurationfor a delivery system;

FIG. 16 is a detail view of the gear train mechanism of the deliverysystem of FIG. 15;

FIG. 17 is a detail cutaway elevation view of the delivery system ofFIG. 15 shown in a starting position;

FIG. 18 is a detail cutaway elevation view of the delivery system ofFIG. 15 shown in a full spring recoil position;

FIG. 19 is a detail cutaway elevation view of the delivery system ofFIG. 15 shown in a fired position;

FIG. 20 is an elevation view of a continuous NiTi wire form fastener inpre-deployment position;

FIG. 21 is an elevation view of the continuous NiTi wire form fastenerof FIG. 20 in post-deployment position;

FIG. 22 is a bottom elevation view of a straight leg, blunt tipcontinuous wire form fastener;

FIG. 23 is a bottom elevation view of a curved leg, blunt tip continuouswire form fastener;

FIG. 24 is a bottom elevation view of a molded tip continuous wire formfastener;

FIG. 25 is an elevation view of a continuous NiTi wire form fastenerwith ground tips in post-deployment external position;

FIG. 26 is an elevation view of a continuous NiTi wire form fastenerwith ground tips in post-deployment internal position;

FIG. 27 is a bottom elevation view of the continuous NiTi wire formfastener with ground tips of FIG. 26 in post-deployment internalposition;

FIG. 28 is an elevation view of a radial slide fastener with straightlegs and a staple guide;

FIG. 29 is an elevation view of the radial slide fastener of FIG. 28;

FIG. 30 is an elevation view of a radial slide fastener with curvedlegs;

FIG. 31 is an elevation view of a two-part fastening system beforeinstallation;

FIG. 32 is an elevation view of the two-part fastening system of FIG. 31after installation;

FIG. 33 is an elevation view of another two-part fastening system beforeinstallation;

FIG. 34 is an elevation view of the two-part fastening system of FIG. 33after installation;

FIG. 35 is an elevation view of a stand-alone fastener incorporated intoa device;

FIG. 36 is an elevation view of another stand-alone fastenerincorporated into a device;

FIG. 37 is an elevation view of another stand-alone fastenerincorporated into a device;

FIG. 38 is an elevation view of another stand-alone fastenerincorporated into a device;

FIG. 39 is an elevation view of another stand-alone fastenerincorporated into an injection port in a pre-installation position;

FIG. 40 is an elevation view of the stand-alone fastener of FIG. 39 in apost-installation position;

FIG. 41 is an elevation view of a helical coil fastener;

FIG. 42 is an elevation view of another helical coil fastener;

FIG. 43 is a top view of a horizontal coil fastening system base;

FIG. 44 is a side view of the horizontal coil fastening system base ofFIG. 43;

FIG. 45 is a bottom view of the horizontal coil fastening system base ofFIG. 43;

FIG. 46 is an elevation view of a driver tool of a fastening system forthe horizontal coil fastening system of FIG. 43;

FIG. 47 is a detail view of the horizontal coil fastening system base ofFIG. 43;

FIG. 48 is a side view of a closed metal loop fastening systemincorporated into a device;

FIG. 49 is a top view of device incorporating the closed metal loopfastening system of FIG. 48;

FIG. 50 is a side view of a two-part snap fit fastening system;

FIG. 51 is an elevation view of a another closed metal loop system usingcurved pins or hooks;

FIG. 52 is a side view of the closed metal loop system using the curvedpins or hooks of FIG. 51 incorporated into a device;

FIG. 53 shows top and side views of a curved pin fastening systemincorporated into a device;

FIG. 54 shows top and side views of another curved pin fastening systemincorporated into a device;

FIG. 55 shows bottom and side view of a spring screw fastening system;

FIG. 56 shows side view of a folding baseplate with curved fasteners inits open and closed positions;

FIG. 57 shows top and side views of rotating hook fasteners incorporatedinto a device;

FIG. 58 is a top elevation view of a rotating disc fastening system withfasteners in pre-deployment position;

FIG. 59 is a bottom elevation view of the rotating disc fastening systemof FIG. 58 with fastener in post-deployment position;

FIG. 60 is a bottom view of the rotating disc fastening system of FIG.58 with fasteners in post-deployment position;

FIG. 61 is a side view of the rotating disc fastening system of FIG. 58with fasteners partially deployed;

FIG. 62 is an elevation view of the curved fastener of the rotating discfastening system of FIG. 58 showing the axis of rotation;

FIG. 63 is cutaway side view of a delivery system;

FIG. 64 is a side elevation view of a delivery system;

FIG. 65 is a top view of the actuator lever of the delivery system ofFIGS. 63 and 64;

FIG. 66 is a side view of the actuator lever of the delivery system ofFIGS. 63 and 64;

FIG. 67 is a bottom view of the actuator lever of the delivery system ofFIGS. 63 and 64;

FIG. 68 is a side elevation view of the actuator lever of the deliverysystem of FIGS. 63 and 64;

FIG. 69 is a partially exploded and cutaway view of the port cover ofthe delivery system of FIGS. 63 and 64;

FIG. 70 is a partial cutaway view of the port cover of the deliverysystem of FIGS. 63 and 64;

FIG. 71 is a back view of the port cover of the delivery system of FIGS.63 and 64;

FIG. 72 is an elevated side view of the port cover of the deliverysystem of FIGS. 63 and 64;

FIG. 73 is an elevated bottom view of a loading fixture;

FIG. 74 is a bottom view of a loading fixture;

FIG. 75 is an elevated view of a loading fixture;

FIG. 76 is an elevated view of a disc fastener/port/loading fixtureassembly; and

FIG. 77 is an exploded view of a disc fastener/loading fixture assembly.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

The present invention encompasses surgical fastening systems wherein animplantable device either contains a plurality of fasteners (e.g.staples) in pre-deployment position, or wherein fasteners are providedadapted to suture holes on the device, or wherein an implantable devicemay have a detachable housing fitted over the device, wherein thehousing contains a plurality of fasteners in pre-deployment position.

The detachable housing and fasteners may be made of various materialsknown in the art for the manufacture of surgical fasteners and implants.The fasteners may be made of metal, polymer, or other suitablematerials. The detachable housing may be made of metal, polymer,ceramic, or composites; for instance polysulfone, acetyl copolymers,titanium, elastomers and stainless steel are commonly used.

These materials must be biocompatible, i.e., they do not adverselyaffect the surrounding living environment, and conversely, theirperformance is not adversely affected by the surrounding livingenvironment. The materials may be inert non-absorbable or biodegradable.Inert materials may be fairly indestructible and maintain their form andfunction for extended periods of time.

Metals and metal alloys, and particularly titanium and titanium alloys,are used for a great variety of implantable articles for medicalapplications. All implantable articles suffer from some degree ofbio-incompatibility, which may be manifested as tissue inflammation,necrosis, hyperplasia, mutagenicity, toxicity, and other reactions, suchas attack by giant cells, leukocytes and macrophages. While titanium andits alloys are generally considered inert when implanted, somebiological and biochemical interactions still may occur, and others havefound it desirable to provide various coatings on the surface oftitanium and titanium alloy implants for certain purposes. The sameholds true for many other metals and metal alloys. Thus, the presentinvention encompasses the use of such coatings on the surface of thefasteners, the removable housing, or the device.

Some of the coatings that may be used in materials to be implanted(whether made of titanium or other materials) include biological agents(such as genetic material or cellular material) or chemical agents (suchas anti-proliferation reagents or cell-growth factors) to reduceproblems associated with hyperplasia or inflammation. These agents maybe mixed with binders such as elastomers or bio-resorbable polymers tothe surface of a metal or polymer object.

The fasteners contemplated herein, including staples, are oftenconstructed of wire and thus have a relatively large surface area fortheir size. Accordingly, methods that allow the addition of biologicaland biochemical agents to the surface of the implant may be advantageousin minimizing the adverse reactions of body tissues with the implant.These may include coatings applied to stainless steel and titaniumalloys (e.g., NiTi alloys) to retard tissue reactions. Such coatingshave been based upon stable bio-compatible polymers (such asstyrene-isobutylene-styrene (SIBS)) and bio-resorbable polymers, such aspolyglycolic acid. In the work known to date, the active chemical orbiological agent is mixed with the polymeric coating material, and theagent then elutes from the coating once the implant is placed in thebody.

It is also contemplated by the present invention that the fasteners maybe made of shape memory alloy (SMA). The driving force for making metalmedical devices from shape memory alloys lies in their great resistanceto permanent deformation as compared to conventional alloys employed inthis application. Alloys used in various medical instruments have reliedon stainless steel, high nickel alloys such as Elgiloy™ and titaniumbased alloys, all of which can be given quite high yield strengththrough work hardening. Normal metals, even with very high yieldstrength, cannot sustain strains much greater than 0.2% withoutsuffering a permanent set. Once a bend or kink has been sustained in adevice fabricated from one of the above conventional alloys it isvirtually impossible to remove. The unusual property of pseudoelasticityexhibited by shape memory alloys such as Au—Cd, Cu—Zn—Al, Ni—Ti and manyothers makes possible the complete “elastic” recovery of strains asgreat as 10%. Due to its high recoverable strain and its excellentresistance to corrosion, the shape memory alloy of preference formedical components has been within the Ni—Ti family of alloys.

Shape memory alloys belong to a class which exhibit thermoelasticmartensite transformation. The term martensite refers to the crystallinephase which is produced in steels when quenched from a high temperature.The phase which exists at the elevated temperature is referred to asaustenite; these terms have been carried over to describe thetransformations which occur in shape memory alloys. When a steel hasbeen quenched from the austenitic temperature to martensite, to againform austenite requires heating the structure to quite hightemperatures, usually in excess of 1400° F.

By contrast, the thermoelastic shape memory alloys can change frommartensite to austenite and back again on heating and cooling over avery small temperature range, typically from 18 to 55° F. Thetransformation of a shape memory alloy is usually described by ahysteresis curve in which it is shown that on cooling from theaustenitic phase, often called the parent phase, martensite starts toform at a temperature designated as MS and upon reaching the lowertemperature, M_(F), the alloy is completely martensitic. Upon heatingfrom below the M_(F) temperature, the martensite starts to revert to theaustenitic structure at A_(S), and when the temperature designated asA_(F) is reached, the alloy is completely austenitic. These two phasesor crystalline structures have very different mechanical properties: theYoung's Modulus of austenite is ˜12×10⁶ psi, while that for martensiteis ˜4×10⁶ psi; and the yield strength, which depends on the amount ofcold work the alloy is given, ranges from 28 to 100 ksi for austeniteand from 10 to 20 ksi for martensite.

The unique feature of shape memory alloys is their ability to recoverdeformation. When a shape memory alloy specimen, in its martensitic formis subjected to stress, the strain is accommodated by the growth andshrinkage of individual martensite variants rather than by themechanisms which prevail in conventional alloys: slip, grain boundarysliding and dislocation motion. When deformed martensite is heated tothe austenite finish temperature A_(F), the part reverts to its originalundeformed state. Thus, for medical implant uses, it is possible todevelop a design where the device is stored below body temperature inits unformed shape, and upon insertion into the body, the temperature ofthe device raises to that of the body, at which point the device revertsto the austenitic structure. In the instant application, the fastenersmay be optionally made of an SMA such as NiTi.

It is within the scope of the present invention that such fasteningsystems as herein described are able to be fastened into bodily tissuein less time than would be required to suture the device into place. Inthe instance described here (the placement of an access port for agastric band), the placement and fixation of the fastening system shouldtake no more than five minutes. Additionally, the fixation system isable to be entirely unfastened and removed from the tissue in order tofacilitate repositioning of the device, or to remove the implanteddevice entirely. Such implantation and extraction will not causeincreased trauma to the patient, and the fixation system will not causemore adhesions than the traditional suturing method. The average surgeonor other health professional is reliably and consistently able toperform fixation and extraction of the fastening system.

Additionally, during the manufacture of such fixation systems describedherein, the size of the fasteners determines the depth into the bodilytissue into which the fasteners will deploy. In the instant case,fixation of an access port should occur at a depth below the device notto exceed 3 mm. Also, in such a use, the bodily tissue into which thefasteners are deployed is the fascia. However, it is within the scope ofthe invention that the bodily tissue to which the device is attachedwill vary depending on the specific device. Additionally, the attachmentof the fastening system into tissue will not cause tissue damage duringplacement or during body motion; for example, an access port for agastric band is often attached directly over the rectus abdominis.Further, the fixation of the device is of equivalent or greater strengthto sutures and resists becoming dislodged or disconnected in order toaccommodate a long-term implant.

The invention as described herein may be used with any type ofimplantable device. Examples of such would include internal monitors,ports, pacemakers, therapeutics, drug delivery systems,neurostimulators, orthopedic devices, tendon repair, etc. For ease ofexplanation, the invention will now be described as depicted in FIGS.1-40, wherein the invention is shown used in conjunction with an accessport. One of skill in the art will recognize that the present inventionmay be used with other types of implantable devices, and that theinvention may take other forms analogous to those depicted herein.

Additionally, in the accompanying figures, the housing is shaped as aring, and may accordingly be described as such. However, one of skill inthe art will recognize that the shape of the housing is dependent onthat of the device, such that the present invention is not limited todevices in which the housing would be circular.

FIG. 1 depicts an access port fastening system according to oneembodiment of the present invention. The access port 10 includes aseptum 11, which in practice is pierced by a needle to input fluid suchas saline into the access port for use with, for example, a hydraulicoperated gastric band.

The access port 10 includes a detachable housing 12 which surrounds theouter perimeter of the access port. The housing 12 includes notches oropenings 15. The notches house fasteners 14. The notches or openings 15may take any form necessary to adequately house the fastener 14 whileallowing movement of the fastener 14. It is within the scope of theinvention that at least three fasteners 14 be present in order tominimize the possibility of movement or dislodgement of the device. Asshown in FIGS. 1-4, the fasteners 14 are attached to the ring 12 by aperpendicular segment engaged through a hole and thereby pivotallyconnected to the ring 12. The fasteners 14 have a first position asshown in FIGS. 1 and 3 and a second or secured position as shown inFIGS. 2 and 4. To move from the first to the second position, thefastener rotates about an axis of the fastener. The notch 15accommodates this rotation and a small locking tab holds the fastener inposition after rotation. In one embodiment, the fasteners 14 may be2-legged staples. In another embodiment, the staples are rigid, suchthat they do not deform during the rotation into the fascia of apatient. For such applications conventional metals are suitable.Furthermore, the staples may be shaped as a “U” or variations thereof,including substantially shaped as:

When in the second position, the fastener 14 is held rigidly in place bya locking tab 16, and fastener 14 may flex to allow the fastener to passinto the locked position. The formation of the locking tab 16 may besuch that upon movement of the fastener 14 from the first to the secondposition an audible click is heard by the surgeon to indicate that thefastener 14 is fully engaged by the locking tab 16. The click may alsobe tactile, allowing the surgeon to feel that the fastener is fullyengaged by locking tab 16. When in the second position an access port 10is secured within the housing 12 in the patient by the fasteners 14which interface with the fascia of the patient. Essentially, the fasciaor other bodily tissue is secured between the fasteners 14 and thehousing 12 or device 10. Furthermore, the housing 12 may contain pegs(not shown) which engage suture holes (not shown) which surround theperimeter of the device 10.

FIGS. 5-8 depict the access port of FIG. 1 and its interaction with anaccess port delivery system 20. As shown in FIG. 5, the access portdelivery system 20 may have a finger depression 25 which is used by theoperator to help hold the access port and the delivery system in placeand properly aligned.

The delivery system 20 comprises a port cover 21. The port cover 21houses a plunger 22, a slide pusher 24, and a slide assembly 26. Theport cover may be formed in any shape necessary to substantially coverthe access port 10.

The plunger 22 provides the operative means for the delivery system 20and is connected to a firing means which will be described below. Uponactuation of the firing means the plunger 22 moves in the direction ofthe access port 10. This movement causes the slide pusher 24 to beactuated. The slide pusher 24 transfers the energy of the moving plunger22 to the slide assembly 26. The slide assembly 26 has a substantiallyround shape and encircles the access port 10. In other applications, theslide assembly may take a form suitable to the device and housing to beimplanted. Upon actuation, the slide assembly 26 is forced in thedirection of the access port 10. Alignment tabs 30 assist the alignmentof the slide assembly 26. The alignment tabs 30 are attached to the portcover 21 and interact with the access port 10 to ensure properalignment. The movement of the slide assembly 26 causes beams 28attached to the slide assembly 26 to act upon the fasteners 14. Theimparting of force on the fasteners 14 allows them to rotate in the ringholes (not shown) and to transcribe an arc defined substantially by thenotch 15. This rotation coincides with a movement from the first to thesecond position discussed above. As the beams 28 continue to be movedtowards the access port 10, the fasteners 14 reach the second positionand are held in place by the locking tabs 16. In this position theaccess port 10 is rigidly held in place by the fasteners 14 and theirinteraction with the fascia or other tissue of the patient.

FIG. 9 shows an access port delivery system complete with a firing means40. FIG. 10 shows a cross sectional view of the firing means 40 in thestarting or loaded position. In this position, the spring 42 iscompressed, and a latch 44 that is connected to a rod 46 is secured by arib 48 to prevent the compressed spring 42 from expanding. The firingmeans has a trigger 50 connected to a lever 52. As shown in FIG. 10 thespring 42 and rod 46 are in a housing 54.

As shown in FIG. 11, upon application of a predetermined force to thetrigger 50, the lever 52 acts on the housing 54. The housing 54 pivotson a fulcrum (not shown), this pivoting action lifts the latch 44 abovethe end of the rib 48. Upon lifting, the spring force of the compressedspring 42 drives the plunger 22 in the direction of the access port andactuates the mechanism therearound as discussed above. In such aconfiguration the plunger travel, speed and impact force can bedetermined to meet the application needs. As tested, the plunger travelwas between 0.25 and 0.75 in, and can develop up to 50 lb. of force onthe plunger, depending upon the spring used in the application.

An alternative to the spring driven mechanism is shown in FIG. 12. FIG.12 shows a palm grip actuated firing mechanism 60. The palm grip is avery simple design requiring only a single moving part to move theplunger 22. In a first position as shown in FIG. 13, there is a movinghandle 61, a stationary handle 62, a pivot point 64, and an actuatingtip 66.

In operation the user squeezes on the moving handle 61 forcing it in thedirection of the stationary handle 62. This movement forces theactuating tip 66 which is connectively engaged with the moving handle 61and the pivot point 64 in a direction opposite the direction of movementof the movable handle 61. Through the use of the simple lever action, acomparatively small force applied to the moving handle 61 is amplifiedthrough the pivot point 64 and applied by the actuating tip 66 to theplunger 22. The plunger 22 is moved by the actuating tip 66 in thedirection of the access port 10 and actuates the mechanism therearoundas discussed above. The force produced by the palm grip actuated deviceis limited only by the strength of the user, as tested the device wascapable of producing in excess of 50 lb. of force with a plunger travelof 0.25 in. Alternatively, a geared mechanism could be produced thatcould produce equal or greater force although require a greater traveldistance for the moving handle 61. The force produced by the deviceshown in FIGS. 12-14 could also be altered as necessary by moving thepivot point 64 nearer the plunger 22 to produce more force, or away fromthe pivot point to produce less force.

Yet another alternative firing means is shown in FIGS. 15-19. The pistolgrip firing means 70 includes a trigger 72 having geared teeth 73located on one end, a gear 74 which meshes with the geared teeth 73, arack 75 driven by the gear 74, and a spring 76. The rack may alsoinclude a means 78 for gripping the plunger 22.

The operative progression is shown in FIGS. 17-19. In FIG. 17, thetrigger is extended and the spring is under little or no tension. Thegeared teeth 73 are meshed with corresponding teeth of the gear 74 andwith teeth on the rack 75. The plunger 22 is in the extended position.When the trigger 72 is depressed, the geared teeth 73 actuate the gear74 and in turn cause the rack 75 to compress the spring 76, as shown inFIG. 18. At a predetermined distance the geared teeth 73 no longerengage the gear 74. At this point the gear 74 is free to spin. Thestored energy in the spring 76 forces the rack 75 to move toward theplunger 22. The free spinning gear 74 allows the rack 75 to move, whichin turn forces the plunger towards the access port 10 and actuates themechanism therearound as discussed above.

Another feature which may be incorporated into the pistol grip firingmeans 70 is a lock (not shown), which after the spring 76 is compressedprevents the gear 74 from spinning. Then when desired the operator canrelease the lock, thereby allowing the spring 76 to expand as discussedabove.

As tested, the pistol grip firing means 70 permits the plunger to travelapproximately 0.4 in and can produce in excess of 50 lb. of force. Onedistinct advantage of this embodiment over, for example, the movablegrip device discussed above is the instantaneous deployment having avery high impact speed.

In FIG. 20 a further embodiment of the present invention is shown. Theuse of NiTi or SMA alloy materials is well known in the medical arts asdiscussed above. As shown in FIG. 20 NiTi fasteners are shown in apre-deployment state. The fasteners 14 are continuous and attached tothe access port 10 through holes therein. In operation the fasteners 14are depressed into the fascia of the patient to secure the access port.The NiTi fasteners 14 have the unique ability to change their shape whenheated, e.g. to body temperature. As shown in FIG. 21, when thefasteners are deployed they can change shape to bend under the accessport 10 and secure it in place.

In FIG. 22 the fasteners 14 are shown with straight legs 80 in adeployed state. Alternative configurations include curved legs 81 asshown in FIG. 23. Using the curved legs 81, the fascia can be pinchedbetween the fastener and the underside of the access port. A furtheralternative is shown in FIG. 24 where the tips of the fastener legs 81are coated with a molded tip 82. The molded tip may be formed in a shapethat will assist in piercing the fascia of the patient. This eliminatesthe need to form the fastener 14 into a shape for piercing.Additionally, the tips 82 may be formed of a bio-absorbable material.

In another embodiment of the present invention, the NiTi fastener can becontinuously formed in a ring 84. The use of the ring 84 allows for thefasteners 14 to be formed with a continuous construction. After the ring84 with the fasteners 14 is formed, the ends of the legs 80 can beground off to produce individual substantially U-shaped fasteners 14.The ring 84 insures that the fasteners 14 can be inserted as a unit asdiscussed above, and the grinding of the legs ensures a sufficientlysharp point to pierce the fascia. As shown in FIGS. 25 and 27, the legscan be formed and positioned in the ring 84 so that after bending due toheating, the legs 80 face internally to the access port 10 or externallyto the access port 10.

Yet another embodiment of the present invention is a two-part fasteningsystem as shown in FIGS. 28-34. FIG. 28 shows a guide 90 formed with aplurality of individual fasteners 14. The fasteners 14 are slidable inthe guide 90 from a first to a second position. In operation the guide90 is placed over the access port 10 and aligned with notches 15. Thefasteners 14 are formed of a spring like material and shaped to attachto the access port 10. The fasteners 14 are slid from a first positionas shown in FIG. 28 to a second position as shown in FIG. 29. Thefasteners 14 pierce the fascia and securely hold the access port 14thereto. As previously described, the fasteners may have straight orcurved legs. After the sliding of all of the fasteners from the guide 90onto the access port 10, the guide may be removed if it is not part ofthe final implanted device. Alternatively, the guide 90 may also be apermanent part of the implantable device.

A further two-part fastening device includes a pre-formed ring 100 (FIG.31 and FIG. 32). The ring includes a first securing means 104 forattaching the ring 100 to the fascia. The ring also includes a secondsecuring means 102 for attaching an access port 10 to a secured ring100. In operation, the ring 100 is placed upon the fascia and thentwisted to engage the fascia in the first securing means 104. The accessport 10 is then placed upon the ring 100 and engages the second securingmeans 102 via holes 106 in the access port. This design allows forpositive attachment and re-installation repeatability withoutdisengaging the pre-formed ring.

FIG. 33 and FIG. 34 depict yet another two-part fastening devicecomprising an applicator 112 and a ring 110 having NiTi fasteners 114.In practice, the ring 110 is inserted into the applicator 112. Theapplicator 112 is placed over the access port 10 with the fasteners 114aligned with notches 115 and holes 106. The fasteners 114 are forcedthrough the holes 106 and engage the fascia of the patient upon whichthe access port 10 rests. Through the heating process, the fasteners 114change shape and secure the access port to the fascia. After apredetermined time, the applicator can be removed.

Another embodiment of the present invention regards stand alonefasteners. As shown in FIGS. 35-38, a variety of designs can be used tosecure an access port 10 to the fascia of a patient. The fasteners mayincorporate NiTi so that the fasteners change shape upon application ofa predetermined amount of heat. These fasteners 14 may be insertedsingularly, or as part of a pre-formed ring as discussed above. Wheninserted singularly, the fasteners 14 may be straight rods or may havesome pre-formed shape which may be heightened through the heatingprocess. In FIG. 35, the fastener 14 takes on a curly, pig-tail shape.In FIG. 36 the fastener takes on a substantially C-shaped appearance.FIGS. 37 and 38 use U-shaped fasteners 14, the ends of which bend,linearly when heated to form an omega shape as shown in FIG. 37, orperpendicularly to the shape as shown in FIG. 38. These shapes can bechosen as desired for a specific application.

Yet another embodiment of the present invention is shown in FIG. 39. InFIG. 39 the fasteners 14 are slidably installed in the access port 10.This may be accomplished by cold molding of the NiTi fastening systeminto the device, and allows positive attachment and repeatablere-positioning. Through the use of an installation tool 120, thefasteners are forced through holes in the bottom of the access port 10and engage the fascia. By installing the fasteners as an integral partof the access port 10, no ring or housing is needed as discussed abovefor housing the fasteners. The installation tool 120 could be part of atriggering device as disclosed herein. FIG. 40 shows the fastener 14 inthe engaged position.

As described above and shown in FIGS. 1-8, radial pivot fasteners are asimple delivery system, with direct drive. The associated deliverysystem actuates the pivot for radial entry. The staple may be stainlesssteel, titanium, Nitinol or Elgiloy™, or other suitable materialsincluding other metals or plastics. The molded pivot/lock-out system maybe designed to snap into the existing suture holes on implantabledevices. Additionally, the simple staple shape allows for easymanufacturability. Such a system is self-puncturing, i.e. nopre-puncturing of the bodily tissue, e.g. fascia, is necessary. Thecurved nature of the staple allows the penetration into the bodilytissue as the staple advances to be predictable; and the pivoting natureof the curved staple generates an easy path through the tissue. Removalof the fastening system requires an extraction tool, and the stapleswill rotate out of the original entry path with only small resistancefrom ingrown surrounding tissue. However, the force required to removethe system is adequate to allow the staples to remain locked in positionexcept during a removal procedure.

Continuous wire forms of the fastener system contemplated herein includeblunt tips, molded tips, and ground or chopped tips. Blunt tipcontinuous wire systems, as shown in FIGS. 20-23 may requirepre-puncture for insertion of the blunt tipped wire. The fastenerassembly may be manufactured to require the locking feature to retaineither the wire form or the overmolded ring. The simple wire form may bemade of stainless steel, titanium, Elgiloy™, NiTi or other suitablematerials. Removal of the fastener assembly may be done easily due tothe blunt ends, which provide minimal tissue damage and trauma.Additionally, the blunt tip reduces the force necessary to remove theassembly. The continuous wire form assembly with molded tips, shown inFIGS. 20 and 24, does not require pre-puncture of the bodily tissue, andthese tips allow for easy entry into the bodily tissue. Further, thechopped or ground blunt end continuous wire form assembly, FIGS. 25-27,also requires no pre-puncture of the bodily tissue, which also allowsfor easy entry into the tissue.

The radial slide fastener assembly, depicted herein with flat fasteners(FIGS. 28 and 29) and curved fasteners (FIG. 30), requires a largerentry site than the other fastener assemblies. The fasteners create apath through the bodily tissue that is simple and secure, with addedretention in systems utilizing the curved fasteners. Removal of thesystems is accomplished with an associated extraction tool thatwithdraws each fastener from their center position. Alternatively, thefasteners may be manufactured such that removal may be accomplished bylifting the assembly upwards, at which time the fasteners bend to astraightened position, allowing for easy removal.

FIG. 41 depicts a helical coil fastener 201, which may optionally beutilized with a port that features a tubing connector extending from thecenter of the base. The corkscrew-type design is mounted to a separatedisc 203 which snaps to the port at tabs 202, or alternatively may bemounted to the port itself, centered on the base plate. The disc or portis manually affixed to the tissue by rotation of the disc or port, whichcauses the coil to travel on a helical path through the tissue. In oneembodiment, the coil can have a sharpened tip.

A variation of the helical coil fastener is depicted in FIG. 42. FIG. 42depicts a flat spiral spring 204 that is deflected downward to begin itspath through the tissue. The deflecting implement 205 may be withdrawnfollowing implantation, allowing the spring to compress during healing.Compression of the spring will reduce the profile of the implanted coilfastener and can reduce the likelihood of pain induction. Tabs 202 areused for locking a port or other device into the fastener.

FIGS. 43-47 and FIG. 55 depict a horizontal coil implantation system. Inthe horizontal coil system, a metal coil is used horizontally to stitchthe port to the tissue. It is well known that such coils can pierce andhold in tissues from their use as mesh tacks in minimally invasivehernia procedures. In this case, the coil travels parallel to the tissuesurface instead of perpendicularly, as in the helical coil fastenersdescribed above. A small deployment tool 206 is envisioned to aid indriving the coil 208 through the tissue and the mating holes 207 in thebase coil receptacle 209 (see FIGS. 46 and 47). Such holes could bestraight holes through a ridge on the bottom of the base (see FIGS. 44,45 and 47), or curved holes molded into a flat-surfaced base. A top viewof a base is shown in FIG. 43. It is envisioned that the last hole wouldbe blind, and that the end of the coil would be shaped in a crossbarthat could slide over an incline and lock into place, such as into aslot. A variation would feature a path for the coil that curves aroundthe port or base edge, facilitating tool access to the coil. This canalso be accomplished by varying the flexibility of the coil. A tube canbe added to the tool as a shroud in order to keep the rotating coil frompicking up strings of tissue before it travels through the holes.

FIGS. 48 to 62 depict various embodiments of a metal suture system. Thismethod of port fixation involves the creation of one or multiple closedmetal loops below the port base, by using the base itself as a means toclose a loop formed by curved metal members (see, e.g. FIGS. 48 and 52).FIG. 48 illustrates one closed loop, with a single curved metal membershown in its post-deployment position. FIG. 49 is a cutaway top view ofone embodiment of the invention showing the curved metal members 211 intheir pre-deployment position. FIG. 57 depicts both a bottom and sideview of one embodiment of the invention showing the curved metal membersforming a loop with the bottom of the base. FIG. 51 shows curved metalmembers, with the arrows indicating their deployment rotation. Fasteningof a port in the above described manner may be done both with one-pieceand two-piece systems, whereby a two-piece system may have a ring 210that attaches to the port or other device by snap-fitting with tabs 202as shown in FIG. 50. One embodiment includes a deflection tool toseparate the point of the metal member from contact with the baseallowing the member tip to begin its path downward through the tissue.This can be a circular disc or the port itself. After the point hastraveled some distance, the tool is withdrawn, permitting the curvedmember to then follow a path intersecting with the base. Likewise,another embodiment includes multiple members curved in two planes, suchthat rotation of the base affects the creating of multiple loops.

An alternate method to achieve such a loop is with a curved pin 212 thatis inserted through the base after it is in its intended tissuelocation, as seen in FIGS. 53 and 54. Such a pin by nature follows anarc through the tissue and can easily be directed back to the port base.Such a pin can be made to lock in place after full travel by adding aright angle bend 213 to the pin that snaps into a slot 214 on the base,or other such well-known means. A variation on this theme includes anadditional straight section on the end of the pin, parallel to thecurved section. A lever arm 215 is used to drive the curved sectionthrough the base and to the completion of its intended travel.

In yet another embodiment, a two-piece system may be used wherein theport attaches to a folding baseplate 218 with sharp, curved extensions217 (see FIG. 56). The folded plate is placed on the tissue with theextensions pointed toward the tissue. When the baseplate is unfolded(flattened) the extensions are driven 90 degrees in a rotary path (seeFIG. 56). The port is then snapped to the baseplate, locking theextensions in position. In one embodiment, the points of the extensionswould overlap those from the other half, semi-shielding the points.

FIGS. 58-62 illustrate a preferred rotating disc fastener system. Afterbeing placed in its desired location, the device to be implanted issecured to the tissue using a plurality of curved pins or hooks 501(FIG. 62), the tips of which rotate through an arc and are received backin or near the baseplate 510 at the end of their travel. A disc 520within the baseplate 510 rotates, thereby causing lever arms 525 to pushagainst curved hooks 501, which in turn rotate about their fixed axis inthe baseplate through an arc until the rotational travel of the discstops. In the fully deployed position (FIGS. 59 and 60), the tips ofhooks 501 are preferably received back in baseplate 510 to form a closedloop. Alternatively, the tips may form less than a closed loop. Ineither case, it is preferable that the rotating disc 520 locks in placeat the end of its travel to lock the hooks in place. One-way flexiblelocking tabs 527 that engage stops 515 or other locking means may beused to lock the hooks in place by preventing backward rotation of thedisc. A deployment tool or delivery system such as that described abovewith reference to FIGS. 5-19 may be used to fasten the device in place.The linear motion of the plunger 22 and slide pusher 24 is convertedinto rotational motion through a transmission using gearing or otherwell known means.

FIGS. 63-72 illustrate a preferred access port delivery system.Referring to FIG. 63, which shows the port delivery system inpre-deployment position, lever 605 is attached to handle 607 at hinge621. Cable sheath 619 is secured to handle 607 by securing pin 623.Cable sheath 619 encloses cable 617 which is attached to lever 605 atthe handle end of the device at cable stop 615. Cable sheath 619 allowsthe linear motion of cable 617. At the deployment end, cable 617 isattached to actuator lever 701, which is snapped into port cover 631. Ascan be seen from FIGS. 66 and 70, actuator lever 701 and port cover 631have curved lips 721 for gripping the baseplate of a disc fastener.Additionally, actuator lever 701 has groove 723 to allow the actuatorlever to rotate around the baseplate with minimal contact, the onlycontact being from curved lip 721. FIG. 66 shows edge 713 of theactuator lever, which snaps into a matching groove of port cover 631 andsecures the actuator lever but allows its rotational motion. FIG. 65shows a top view of the actuator lever, and shows cable stop 705, wherethe deployment end of cable 617 is attached. Cable 617 runs through slot707 and out through notch 709 and along groove 711. When the user of thedeployment tool pulls lever 605 towards handle 607, cable 617 is pulledthrough the sheath towards handle 607. As the cable is pulled throughthe sheath, it pulls the actuator lever at cable stop 705, causing theactuator lever to rotate along the path prescribed by edge 713 and itscorresponding groove in port cover 631. FIGS. 69 and 70 show partiallyexploded and cutaway detail of the various parts of the actuator lever,port cover and cable assembly. Thus the linear motion of cable 607 isconverted to the rotational motion necessary to deploy the fasteningsystem.

FIGS. 71 and 72 show an embodiment of port cover 631 in greater detail.Attachment position 735 is the location where a cable sheath may attachto the port cover. In addition, both FIGS. 71 and 72 show devicepassageway 737. Device passageway 737 allows a port cover to be attachedto a port or other device without interfering with any tubing or otherinstrumentation that may be running from the port or device. In thisembodiment the passageway is a square shape, however the passageway maybe in a wide variety of shapes to accommodate a variety of devices.

FIGS. 73-77 depict a loading fixture for holding a combined port/discfastener assembly. The port/disc fastener system is snapped into thefixture, which protects the assembly, protects the user from accidentalcontact with the hooks, sharpened points, etc., used to fasten theassembly to tissue, prevents premature deployment of the assembly, andallows the user to load the port/disc fastener system into thedeployment tool without actually touching the assembly. The deploymenttool is snapped onto the assembly while it is still in the loadingfixture. Similar to the device passageway of the port cover, the loadingfixture has device passageway 739 to allow any tubing to hang freelyfrom the device to be attached without any interference from the loadingfixture. FIG. 75 shows how a device may be securely held in place bylocking tabs 743 and/or pegs 741. FIG. 76 shows a port/disc fastenerassembly being held securely by the loading fixture. FIG. 77 shows anexploded view of the disc fastener/loading fixture assembly without aport device attached.

A brief description of the combined use of preferred embodiment of thedisc fastener system shown in FIGS. 58-62, the preferred embodiment ofthe deployment tool of FIGS. 63-68 and the loading fixture of FIGS.73-77 is helpful in understanding the invention. The user grasps theport delivery system at handle 607. The port/disc fastener assemblywould be held in the loading fixture, as shown in FIG. 76. The usermaneuvers the port cover 631 over the port/disc fastener assembly, andcurved lips 721 of the actuator lever and port cover snap-fit with thebaseplate 510, such that an audible and tactile click is heard and feltby the user. The user then pulls the deployment tool from the loadingfixture with the combined port/disc fastener attached and ready to bedeployed. The user then positions the combined port/disc fastener systemsuch that the disc fastener is set in its location for deployment. Oncein place, the user pulls the lever, setting the actuator lever inmotion. Actuation edge 725 engages with a single lever arm 525, rotatingthe lever arms until the fasteners are fully deployed. Upon fulldeployment an audible and tactile click is both heard and felt by theuser, as the port is ejected from the port delivery system, and thedeployment is complete.

Although the invention has been particularly shown and described withreference to certain preferred embodiments, and in particular withreference to an access or injection port, it will be readily appreciatedby those of ordinary skill in the art that any number of implantablemedical devices may be used with the fastening system of the presentinvention and that various changes and modifications may be made thereinwithout departing from the spirit and scope of the invention.

1. An implantable injection port and protective fixture system,comprising: an implantable injection port having a housing defininggenerally an upper face, a lower face, and a peripheral outer wall, aseptum held within the housing and open to the upper face, the septumbeing capable of penetration by a needle along the vertical axis, theport further including a space below the septum defining a fluidreservoir and an outlet conduit through the housing from the reservoir,wherein the port further includes a plurality of fasteners incorporatedinto the housing to enable a user to attach the port to tissue withoutsutures, the fasteners each having an undeployed position and a deployedposition, the deployed position extending below the lower face of theport opposite the upper face; and a protective fixture adapted toremovably attach over the lower face of the housing and cover thefasteners.
 2. The system of claim 1, wherein the fixture resilientlyattaches to the housing with tabs that engage the housing lower face. 3.The system of claim 1, wherein the housing and fixture snap together. 4.The system of claim 1, wherein the fixture includes a main portion thatsnaps to the housing and at least one grasping tab non-detachably fixedto the main portion and extending radially therefrom to facilitateremoval of the fixture from the housing.
 5. The system of claim 1,wherein the outlet conduit extends radially through the housing from thereservoir, and the fixture has a passageway for receiving the outletconduit.
 6. The system of claim 1, wherein the fasteners each pivotallyrotates in the housing from the undeployed position to the deployedposition.
 7. The system of claim 6, wherein the fasteners comprisecurved hooks distributed around the lower face of the port that eachpivots from the undeployed position to the deployed position.
 8. Thesystem of claim 7, wherein sharp tips of the curved hooks rotate throughan arc and are received back in or near the lower face of the port atthe end of their travel.
 9. The system of claim 2, wherein the tabs haveribs that snap onto complementary features on the housing lower face.10. The system of claim 1, wherein the protective fixture includes pegsthat engage the housing lower face.
 11. The system of claim 5, whereinthe protective fixture includes an annular wall that surrounds thehousing, and the passageway defines an interruption in the annular wall.12. An implantable injection port and protective fixture system,comprising: (a) implantable injection port having a housing defininggenerally an upper face, a lower face, and a peripheral outer wall, aseptum held within the housing and open to the upper face, the septumbeing capable of penetration by a needle along the vertical axis, theport further including a space below the septum defining a fluidreservoir and an outlet conduit through the housing from the reservoir,(b) an attachment mechanism comprising at least one fastener forattaching the injection port to a body, the fastener having a deployedposition that extends from a distal end of the injection port, and anundeployed position proximal to the distal end of the injection port;and (c) a loading fixture covering the fastener and removably attachedto the distal end of the injection port to protect a user fromaccidental contact with the fastener.
 13. The system of claim 12,wherein the loading fixture comprises an annular recess which defines aninternal cavity for receiving the injection port.
 14. The system ofclaim 12, wherein the loading fixture comprises at least one graspingtab non-detachably fixed thereto and extending therefrom.
 15. The systemof claim 12, wherein the loading fixture resiliently attaches to theinjection port with tabs that engage the distal end of the injectionport.
 16. The system of claim 12, wherein the tabs have ribs that engagecomplementary features on the distal end of the injection port.
 17. Thesystem of claim 12, wherein the injection port and loading fixture snaptogether.
 18. The system of claim 12, wherein the loading fixtureincludes an annular wall that surrounds the injection port and isinterrupted by a passageway therein to accommodate a reservoir outletconduit extending from the injection port.
 19. The system of claim 12,wherein the fastener pivotally rotates in the injection port from theundeployed position to the deployed position.
 20. The system of claim12, wherein the fastener comprises a curved hook that pivots from theundeployed position to the deployed position.
 21. The system of claim20, wherein a sharp tip of the curved hook rotates through an arc and isreceived back in or near the distal end of the injection port at the endof its travel.
 22. The system of claim 12, wherein the attachmentmechanism comprises a plurality of the fasteners integral to theinjection port that simultaneously deploy from their undeployedpositions to their deployed positions.